Philips is halting sales of its recalled sleep apnea machines in the US after finding they were pumping foam particles into users’ airways. In its earnings report on Monday, the company says it will not sell new CPAP or BiPAP devices in the US until it meets the requirements outlined by the Food and Drug Administration.
Philips first issued a recall on its sleep apnea machines in 2021 over “potential health risks.” The recall includes devices made between 2009 and April 21st, 2021, and stems from a polyester-based polyurethane foam Philips included in the machines to minimize sound and vibration. As noted by Philips, that foam “can break down,” leading the person using the device to breathe it in or swallow it, resulting in potential injury.
The company says it has reached a consent decree with the Department of Justice and FDA. It doesn’t go into detail about the terms of the agreement because it is still pending approval by a court. However, we do know that Philips will still provide service to sleep and respiratory devices in the US and will also continue to sell the machines outside of the US. Philips, which is headquartered in the Netherlands, has set aside €363 million (about $394 million) to address the FDA’s requirements.
Last year, ProPublica and the Pittsburgh Post-Gazette found that Philips received complaints about the machines as early as 2010 but withheld customer concerns from the FDA. Philips has since agreed to pay a $479 million settlement to those who purchased any of the recalled devices.